System for improving cardiac function by sealing a partitioning membrane within a ventricle

ABSTRACT

Partitioning devices that may be secured and sealed within a heart chamber for separating a patient&#39;s heart chamber into a productive portion and a non-productive portion are described herein. The partitioning devices described herein may include a reinforced membrane with outwardly biased members. The reinforced membrane may have a central hub with a distally extending support stem with a plurality of feet which extend radially from a centerline axis and preferably have ends that are aligned in a common plane. These devices may be secured within the heart chamber by sealing them to the wall of the heart chamber, for example, by inflating an inflatable element on the periphery of the device. The non-productive portion may be filled with a material, including occlusive materials. Sealing and/or filling the non-productive portion formed by the devices described herein may help prevent leakage from the non-productive region. Also described herein are systems including these devices and methods of using them, which may be suitable for treating patients with heart disease, particularly congestive heart failure.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application claims priority as a continuation-in-partapplication of U.S. patent application Ser. No. 10/436,959, titled“System for Improving Cardiac Function”, filed May 12, 2003 which claimspriority as a continuation-in-part of U.S. patent application Ser. No.09/635,511, filed on Aug. 9, 2000 (now abandoned) which claimed priorityto provisional patent application Serial No. 60/147,894 field on Aug. 9,1999. This patent application also claims priority as acontinuation-in-part application of U.S. patent application Ser. No.11/151,164, titled “Peripheral Seal for a Ventricular PartitioningDevice,” filed Jun. 10, 2005.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD OF THE INVENTION

The devices, systems and methods described herein relate generally tothe treatment of heart disease, particularly congestive heart failure,and more specifically, to devices, systems and methods for partitioninga patient's heart chamber and a system for delivering the treatmentdevice.

BACKGROUND OF THE INVENTION

Congestive heart failure (CHF) is characterized by a progressiveenlargement of the heart, particularly the left ventricle and is a majorcause of death and disability in the United States. Approximately550,000 new cases occur annually in the U.S. alone. As the patient'sheart enlarges, it cannot efficiently pump blood forward with each heartbeat. In time, the heart becomes so enlarged the heart becomesineffective as a pump and cannot adequately supply blood to the body.Even in healthy hearts only a certain percentage of the blood in apatient's left ventricle is pumped out or ejected from the chamberduring each stroke of the heart. The pumped percentage, commonlyreferred to as the “ejection fraction”, is typically about sixty percentfor a healthy heart. A patient with congestive heart failure can have anejection fraction of less than 40% and sometimes much lower. As a resultof the low ejection fraction, a patient with congestive heart failure isfatigued, unable to perform even simple tasks requiring exertion andexperiences pain and discomfort. Further, as the heart enlarges, theinternal heart valves such as the mitral valve cannot adequately close.An incompetent mitral valve allows regurgitation of blood from the leftventricle back into the left atrium, further reducing the heart'sability to pump blood forwardly.

Congestive heart failure can result from a variety of conditions,including viral infections, incompetent heart valves (e.g. mitralvalve), ischemic conditions in the heart wall or a combination of theseconditions. Prolonged ischemia and occlusion of coronary arteries canresult in myocardial tissue in the ventricular wall dying and becomingscar tissue. Once the myocardial tissue dies, it is less contractile(sometimes non-contractile) and no longer contributes to the pumpingaction of the heart. It is referred to as hypokinetic or akinetic. Asthe disease progresses, a local area of compromised myocardium may bulgeout during the heart contractions, further decreasing the heart'sability to pump blood and further reducing the ejection fraction. Inthis instance, the heart wall is referred to as dyskinetic. Thedyskinetic region of the heart wall may stretch and eventually form ananeurysmic bulge.

Patients suffering from congestive heart failure are commonly groupedinto four classes, Classes I, II, III and IV. In the early stages,Classes I and II, drug therapy is presently the most common treatment.Drug therapy typically treats the symptoms of the disease and may slowthe progression of the disease, but it cannot cure the disease.Presently, the only permanent treatment for congestive heart disease isheart transplantation, but heart transplant procedures are very risky,extremely invasive and expensive and are performed on a small percentageof patients. Many patient's do not qualify for heart transplant forfailure to meet any one of a number of qualifying criteria, and,furthermore, there are not enough hearts available for transplant tomeet the needs of CHF patients who do qualify.

Substantial effort has been made to find alternative treatments forcongestive heart disease. For example, surgical procedures have beendeveloped to dissect and remove weakened portions of the ventricularwall in order to reduce heart volume. This procedure is highly invasive,risky and expensive and is commonly only done in conjunction with otherprocedures (such as heart valve replacement or coronary artery by-passgraft). Additionally, the surgical treatment is usually only offered toClass III and IV patients and, accordingly, is not an option for mostpatients facing ineffective drug treatment. Finally, if the procedurefails, emergency heart transplant is the only presently availableoption.

Mechanical assist devices have been developed as intermediate proceduresfor treating congestive heart disease. Such devices include leftventricular assist devices and total artificial hearts. A leftventricular assist device includes a mechanical pump for increasingblood flow from the left ventricle into the aorta. Total artificialheart devices, such as the Jarvik heart, are usually used only astemporary measures while a patient awaits a donor heart for transplant.

Recently, improvements have been made in treating patients with CHF byimplanting pacing leads in both sides of the heart in order tocoordinate the contraction of both ventricles of the heart. Thistechnique has been shown to improve hemodynamic performance and canresult in increased ejection fraction from the right ventricle to thepatient's lungs and the ejection fraction from the left ventricle to thepatient's aorta. While this procedure has been found to be successful inproviding some relief from CHF symptoms and slowed the progression ofthe disease, it has not been able to stop the disease and is onlyindicated in patients with ventricular dissynchrony.

Other efforts to treat CHF include the use of an elastic support, suchas an artificial elastic sock, placed around the heart to preventfurther deleterious remodeling.

Described herein are ventricular partitioning devices that address manyof the problems associated with devices that reduce heart volume ormodify cardiac contraction. In particular, the devices, systems andmethods described herein may reduce volume in a ventricle in a way thatavoids leakage or the release of potentially thrombogenic materials.

SUMMARY OF THE INVENTION

The present invention is directed to ventricular partitioning devices,systems and methods of employing ventricular partitioning devices in thetreatment of a patient with heart disease and particularly congestiveheart failure (CHF). Specifically, the devices described hereinpartition a chamber of the patient's heart into a main productiveportion and a secondary non-productive portion, and form a seal betweenthe two portions. In some variations, the devices include a separatechamber that is configured to fit within the non-productive portion.Partitioning reduces the total volume of the heart chamber, reduces thestress applied to weakened tissue of the patient's heart wall and, as aresult, improves the ejection fraction thereof. Moreover, the expansivenature of the device improves the diastolic function of the patient'sheart.

In general, the partitioning devices described herein have a reinforcedpartitioning component with a concave, pressure receiving surface whichdefines in part the main productive portion of the partitioned heartchamber when secured within the patient's heart chamber. The reinforcedpartitioning component may include a flexible membrane that forms thepressure receiving surface. The partitioning component may be reinforcedby a radially expandable frame component formed of a plurality of ribs.The ribs of the expandable frame may have secured distal ends, which arepreferably secured to a central hub, and free proximal ends. The distalends of the ribs may be secured to the central hub to facilitate radialself expansion of the free proximal ends of the ribs away from acenterline axis. The distal ends of the ribs may be pivotally mounted tothe hub and biased outwardly or fixed to the hub. The ribs arepreferably formed of material such as superelastic NiTi alloy whichallows for compressing the free proximal ends of the ribs toward acenterline axis into a contracted configuration for delivery andself-expansion when released for deployment to an expanded configurationwhen released within the patient's heart chamber.

The free ends of the ribs may be configured to engage and preferablypenetrate the tissue lining the heart chamber to be partitioned so as tosecure the peripheral edge of the partitioning component to the heartwall and fix the partitioning component within the chamber so as topartition the chamber in a desired manner. The tissue penetratingproximal tips may be configured to penetrate the tissue lining at anangle approximately perpendicular to a center line axis of thepartitioning device. The tissue penetrating proximal tips of the ribsmay be provided with barbs, hooks and the like which prevent withdrawalfrom the tips from the heart wall.

The portioning devices described herein may also include a sealingelement (or sealing elements) configured to seal the device (which maybe separately secured to the heart wall) to the heart wall. For example,the device may include an expansive member such as one or more strands,swellable pads, inflatable balloons, or the like, that extend between atleast one pair of adjacent ribs at or close to the outer edge orperiphery of the membrane to seal the membrane to the heart wall. Forexample, the sealing element may exert pressure to the flexible membraneperiphery when the partitioning device is in an expanded configurationto ensure an adequate seal between the membrane periphery and the liningof the heart wall. In one embodiment, a single strand or strands extendaround essentially the entire periphery of the membrane so that theflexible periphery of the membrane between each pair of ribs iseffectively sealed against the heart wall. The expansive strand orstrands may be formed of material which is stiffer than the flexible,unsupported material of the membrane to provide an outward expansiveforce or thrust to prevent formation of inwardly directed folds orwrinkles when the ribs of the partitioning device are in at least apartially contracted configuration. Suitable strand or strands areformed of material such as polypropylene suture or superelastic NiTialloy wires. Such strands may typically be about 0.005 to about 0.03inch (0.13-0.76 mm) in diameter to provide the requisite outwardexpansive force when placed in a circular position such as around theperiphery of the membrane in less than completely expandedconfiguration.

In another embodiment expandable pads are provided between each adjacentpair of ribs which are configured to swell upon contact with body fluidsto provide an outward expansive force or thrust, as above, to preventformation of inwardly directed folds or wrinkles when the ribs of thepartitioning device are in at least a partially contractedconfiguration. Preferably the pads are formed of expansive hydrophilicfoam. Suitable swellable materials includable collagen, gelatin,polylactic acid, polyglycolic acid, copolymers of polylactic acid andpolyglycolic acid, polycaprolactone, mixtures and copolymers thereof.Other suitable swellable bioresorbable polymeric materials may beemployed. The expandable pads may be formed so as to deliver a varietyof therapeutic or diagnostic agents.

In some variations, the ribs in their expanded configuration typicallyangle outwardly from the hub and the free proximal ends curve outwardlyso that the membrane secured to the ribs of the expanded frame forms atrumpet-shaped, pressure receiving surface.

The partitioning membrane in the expanded configuration may have radialdimensions from about 10 to about 160 mm, preferably about 25 to about50 mm, as measured from the center line axis. The membrane is preferablyformed of flexible material or fabric such as expandedpolytetrafluoroethylene (ePTFE).

The partitioning device may be designed to be oversized with respect tothe chamber in which it is to be deployed so that the ribs of the deviceapply an outward force against the chamber wall. When the partitioningdevice is collapsed for delivery, the outwardly biased strand or strandsensures that there are no inwardly directed folds or wrinkles and thatnone are formed when the partitioning device is expanded for deploymentwithin the heart chamber.

In one partitioning device design, the free ends of the expansive strandor strands may be secured together or to the partitioning device.Alternatively, in another device design, the expansive strand or strandsmay be long enough so that one or both free ends thereof extend out ofthe patient to facilitate collapse and retrieval of the partitioningdevice. Pulling on the free ends of the strand extending out of thepatient closes the expanded portion i.e. the ribs and membrane, of thepartitioning device to collapse of the device and such pulling can pullthe collapsed partitioning device into the inner lumen of a guidecatheter or other collecting device

The reinforced partitioning component may include a supporting componentor stem which has a length configured to extend distally to the heartwall surface to support the partitioning device within the heartchamber. For example, the supporting component may have a plurality ofpods or feet, preferably at least three, which distribute the force ofthe partitioning device about a region of the ventricular wall surfaceto avoid immediate or long term damage to the tissue of the heart wall,particularly compromised or necrotic tissue such as tissue of amyocardial infarct (MI) and the like. Pods of the support component mayextend radially and preferably be interconnected by struts or planeswhich help distribute the force over an expanded area of the ventricularsurface.

Any of the partitioning devices described herein may be deliveredpercutaneously or intraoperatively. Thus, methods of delivery anddevices for delivering them are also described herein. For example, onedelivery catheter which may be used has an elongated shaft, a releasablesecuring device on the distal end of the shaft for holding thepartitioning device on the distal end and an expandable member such asan inflatable balloon on a distal portion of the shaft proximal to thedistal end to press the interior of the recess formed by the pressurereceiving surface to ensure that the tissue penetrating tips or elementson the periphery of the partitioning device penetrate sufficiently intothe heart wall to hold the partitioning device in a desired position toeffectively partition the heart chamber. For example, one variation of asuitable delivery device is described in co-pending application Ser. No.10/913,608, filed on Aug. 5, 2004, and assigned to the present assignee.

For example, described herein are devices for partitioning a patient'sventricle into a productive portion and a non-productive portion, thedevice comprising: a membrane and a membrane support frame sized to spanthe patient's ventricle, wherein the membrane support frame comprises aplurality of support struts configured to have a collapsed and anexpanded configuration; at least one securing element extending from theperiphery of the membrane; and an inflatable sealing element on aperipheral portion of the membrane configured to seal the peripheralportion of the membrane to a wall of the ventricle.

In general, the inflatable sealing element includes swellable sealingelements. A swellable sealing element typically inflates from a smallerprofile to a larger (swelled or inflated) profile. Any of the inflatablesealing elements described herein may be considered expansive membersthat expand in order to secure and/or seal the membrane of the devicesagainst a wall of a heart chamber. In some variations, the inflatablesealing element extends annularly around the perimeter of the membrane.For example, the inflatable sealing element may be a plurality ofinflatable sealing elements extending between the support struts.

The membrane support frame may be configured to form a recess in theexpanded configuration.

Any of the devices described herein may also include a valve configuredto allow access to the non-productive portion when the device isdeployed in the subject's ventricle. In some variations, the valvecomprises a one-way valve.

The membrane may be formed at least in part of a flexible material.

The devices described herein may also include an inflation valve fluidlyconnected to the inflatable sealing element.

The inflatable sealing element may be formed of any appropriatematerial, in particular, the inflatable sealing element may be formed ofa bioabsorbable material. In some variations, the bioabsorbable materialis selected from the group consisting of collagen, gelatin, polylacticacid, polyglycolic acid, copolymers of polylactic acid and polyglycolicacid, polycaprolactone, mixtures and copolymers thereof.

Any of the partitioning devices described herein may also include acentral hub to which the membrane support frame is secured, and/or astem with a non-traumatic distal tip configured to engage a region ofthe chamber defining in part the non-productive portion thereof. Thesecuring elements may be anchors, and may be tissue penetrating. Forexample, the securing elements may have a tissue penetrating tip. Thesecuring element(s) may be outwardly curved.

In some variations, the partitioning device may also include one or morecontainers secured to the device that may be filled once the device isinserted into the ventricle. For example, the device may include acontainer secured to the device and configured to be positioned withinthe non-productive portion of the subject's ventricle when the device isdeployed in the subject's ventricle. The container may be a bag havingflexible walls, or it may have rigid or semi-flexible walls. Thecontainer may be collapsed or foldable. In some variations the membraneconnected to the support frame forms a wall or portion of the container.Thus, the container may extend from the membrane and/or support framedistally, so that it may be positioned within the non-productive portionof the ventricle when the device is deployed. Portions of the device maybe contained within the container. For example, a stem portion, a footportion, etc. may be positioned within the container. The container maybe expandable. For example, the container may be a flexible orstretchable fabric. The container may be configured to hold a fluid orsolid. Thus, in some variations the container is configured to befluid-tight. In some variations the container may be filled with a fluidsuch as saline, blood, etc. In other variations, the container may bepermeable or semi-permeable.

Also described herein are methods for treating a patient, including apatient having a heart disorder, or at risk for a heart disorder. Themethod may include the steps of: percutaneously advancing a contractedpartitioning device into a patient's ventricle; expanding thepartitioning device into a deployed configuration within the ventricle;and sealing the expanded partitioning component to the wall of theventricle to separate the ventricle into a productive portion and anon-productive portion to prevent communication between the productiveportion and non-productive portions.

The method may also include the step of filling the non-productiveportion. For example, the non-productive portion may be filled with abio-resorbable filler such as polylactic acid, polyglycolic acid,polycaprolactone and copolymers and blends. In some variations, thefiller is an occlusive material such as a coil (e.g., vasoocclusivecoil) or the like. Fillers may be suitably supplied in a suitablesolvent such as dimethylsulfoxide (DMSO). Other materials whichaccelerate tissue growth or thrombus may be deployed in thenon-productive portion, as well as non-reactive fillers.

The sealing step may include expanding a sealing element against theventricle wall from the partitioning device. The sealing step mayinclude the step of biasing a membrane toward the heart wall with thesealing element. For example, the expanding step may include inflatingthe sealing element. In some variations, the sealing element may beactively expanded (e.g., by applying air or other fluids), or passivelyexpanded (e.g., by allowing swelling).

Also described herein are methods of treating a patient comprising thesteps of: percutaneously advancing a contracted partitioning device intoa patient's ventricle; expanding the partitioning device into a deployedconfiguration within the ventricle; securing the expanded partitioningdevice to the ventricle wall to separate the ventricle into a productiveportion and a non-productive portion; and adding a filling material tothe non-productive portion.

In some variations, the step of adding a filling material includesapplying material through a valve on the partitioning device. The valvemay be a one-way valve. The material may be applied through a channel inthe applicator. For example, the applicator may engage with a valve onor through the device. In some variations, the device is passivelyfilled. For example, one or more valves may allow the entry of bloodflow behind the device, but may prevent the blood (or any thrombosis)from exiting the non-productive space behind the valve. Thus the step ofadding the filing material may include passively allowing a blood tofill a compartment portion of the partitioning device through a valve onthe device.

In some variations, the step of adding a filling material includesapplying a filling material into a compartment portion of thepartitioning device through a valve. As mentioned above the compartmentmay be filled with any appropriate filling material, including fluids,solids, or some combination thereof. For example, the step of adding afilling material may include applying one or more coils to thenon-productive portion. The coils (e.g., vasooccluisve coils) or otherfilling material may be added to a compartment portion of thepartitioning device. The step of adding the filing material may compriseapplying saline to a compartment portion of the partitioning device.

Also described herein are applicators for applying a partitioning deviceof a ventricle of a patient's heart. An applicator may include: anelongated shaft which has proximal and distal ends; an deployinginflation port on the proximal end of the shaft and an inner lumen influid communication with the port; a releasable securing element on thedistal end of the elongated shaft configured to secure and release thepartitioning device; an inflatable member on a distal portion of theelongated shaft having an interior in fluid communication with thedeploying inflation port, wherein the inflatable member is configured toexpand a membrane of the partitioning device; and a filling interfacenear the distal end of the elongated shaft, wherein the fillinginterface is configured to apply a filling material through a valve onthe partitioning device.

One particular variation of the devices for partitioning a patient'sventricle into a product and non-productive portion includes aninflatable sealing element that is a balloon element. For example,described herein are devices for partitioning a patient's ventricle intoa productive portion and a non-productive portion. Such devices mayinclude a membrane and a membrane support frame sized to span thepatient's ventricle, wherein the membrane support frame comprises aplurality of support struts configured to have a collapsed and anexpanded configuration, at least one securing element extending from theperiphery of the membrane, and an inflatable sealing balloon element ona peripheral portion of the membrane configured to seal the peripheralportion of the membrane to a wall of the ventricle.

As mentioned above, the inflatable sealing balloon element may extendsubstantially around the perimeter of the membrane. In some variations,the partitioning devices include a plurality of inflatable sealingballoon elements extending between support struts.

A partitioning device may also include an inflation port configured toconnect the inflatable sealing balloon element to a channel on adelivery device. The devices may also include an inflation valve fluidlyconnected to the inflatable sealing element.

As mentioned above, the securing element(s) of the partitioning devicemay have a tissue penetrating tip.

These partitioning devices may also include a container secured to thedevice and configured to be positioned within the non-productive portionof the subject's ventricle when the device is deployed in the patient'sventricle.

Also described herein are devices for partitioning a ventricle of apatient's heart into a productive portion and a non-productive portionthat include: a membrane and a membrane support frame, the membrane andthe membrane support frame sized to span the patient's ventricle,wherein the membrane and the membrane support frame are configured tohave a collapsed configuration and an expanded configuration; at leastone securing element on a peripheral portion of the membrane configuredto secure the membrane to a wall of the ventricle; and a containersecured to the device and configured to be positioned within thenon-productive portion of the subject's ventricle when the device isdeployed in the subject's ventricle. The container may be secured to themembrane. In some variations, the membrane forms a wall or portion ofthe container. The container may extend from a peripheral portion of themembrane.

The container may be configured to substantially conform to theventricular wall. For example, the container may be fillable so that itcontacts all or a portion of the ventricle wall in the non-productiveportion of the ventricle. In some variations, the container isconfigured as a bag.

As mentioned above, the container may be expandable, or it may have afixed volume. The container may be made of a flexible material. In somevariations, the container comprises one or more rigid walls. Thecontainer may be permeable or impermeable. In general, the container maybe fillable. For example, the container may be configured to be filledwith a fluid. In some variations, the container is configured to befilled with one or more coils or other occlusive members. The devicesdescribed herein may include a valve providing access into thecontainer. For example, the valve may be configured to permit filling,but not emptying of the container. Thus, in one variation the valve is aone-way valve configured to allow the container to passively fill withblood from the ventricle. In some variations, the container may beconfigured so that the valve can permit emptying.

Any of the features of the partitioning devices described herein may beincluded as part of the portioning devices including a container. Forexample, the devices may include a central hub, a stem, a foot (e.g., anatraumatic foot), or the like. In some variations the device may beconfigured so that one or more of these elements is contained within thecontainer.

Also described herein are methods of treating a patient comprising:percutaneously advancing a contracted partitioning device into apatient's ventricle; expanding the partitioning device into a deployedconfiguration within the ventricle; sealing the expanded partitioningcomponent to the wall of the ventricle to separate the ventricle into aproductive portion and a non-productive portion to prevent communicationbetween the productive portion and non-productive portions; and fillinga container portion of the implant that is secured within thenon-productive portion of the ventricle.

The step of filling may comprise filling the container portion with anocclusive device, or with some other solid and/or liquid material, e.g.,saline.

Also described herein are applicators for applying a partitioning deviceto a ventricle of a patient's heart, the applicator comprising: anelongated shaft which has proximal and distal ends; a deployinginflation port and a sealing inflation port on the proximal end of theshaft; an inner lumen in fluid communication with at least one of theports; a releasable securing element on the distal end of the elongatedshaft configured to secure and release the partitioning device; aninflatable member on a distal portion of the elongated shaft having aninterior in fluid communication with the deploying inflation port; and asealing inflation interface near the distal end of the elongated shaftin fluid communication with the sealing inflation port, wherein thesealing inflation interface is configured to couple to an inflatablesealing element of the partitioning device.

Other variations of partitioning devices having one or more chambers arealso described herein. For example, described herein are ventricularchamber volume reduction systems, comprising: a container bodydeliverable into a portion of a ventricular chamber, and wherein thecontainer body is expandable from a first shape to a second shape whendelivered into the ventricular chamber, the container body having atissue surface in contact with a wall of the ventricular chamber and anexposed surface facing into the volume of the ventricular chamber notoccupied by the container body, and wherein the exposed surfacesubstantially spans across the ventricular chamber, wherein the secondshape of the container body occupies substantially all of the space inthe ventricular chamber between the wall of the portion of theventricular chamber and the exposed surface, thereby reducingventricular volume exposed to a flow of blood. In some variations, thesedevices also include a partition, wherein the partition is positioned onthe side of the container adjacent to the exposed surface.

As mentioned above, the second shape of the container body may occupysubstantially all of the space in the ventricular chamber between thewall of the portion of the ventricular chamber and the exposed surface.For example, when the device is filled with material, one or more wallsof the device may contact the sides of the ventricle in thenon-productive portion of the ventricle.

The container body may include an attachment device that affixes thetissue surface to the wall of the ventricular chamber. For example, thecontainer body may include one or more anchors, hooks, barbs or thelike. In some variations, the container body may include one or morestruts or arms that apply pressure to secure the tissue surface to awall of the ventricular chamber. In some variations the chamber body maybe sealed against the wall of the ventricular chamber by expanding orinflating an inflatable member, as described above. The inflatablemember may be present with the container. In some variations, theexpandable member is present on the outside of the container. Thecontainer may also be expandable and/or inflatable.

A partitioning device embodying features of the invention may berelatively easy to install and may be a substantially improved treatmentof a diseased heart. A more normal diastolic and systolic movement of apatient's diseased heart may thus be achieved. Concomitantly, anincrease in the ejection fraction of the patient's heart chamber can beobtained. These and other advantages of the invention will become moreapparent from the following detailed description of the invention andthe accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational view of a partitioning device embodyingfeatures of the invention in an expanded configuration.

FIG. 2 is a plan view of the partitioning device shown in FIG. 1illustrating the upper surface of the device.

FIG. 3 is bottom view of the partitioning device shown in FIG. 1.

FIG. 4 is a perspective view of the non-traumatic tip of the distallyextending stem of the device shown in FIG. 1.

FIG. 5 is a partial cross-sectional view of the hub of the partitioningdevice shown in FIG. 2 taken along the lines 5-5.

FIG. 6 is a transverse cross sectional view of the hub shown in FIG. 5taken along the lines 6-6.

FIG. 7 is a longitudinal view, partially in section of a reinforcing riband membrane at the periphery of the partitioning device shown in FIG.1.

FIG. 8 is a schematic elevational view, partially in section, of adelivery system with the partitioning device shown in FIGS. 1 and 2mounted thereon.

FIG. 9 is a transverse cross-sectional view of the delivery system shownin FIG. 8 taken along the lines 9-9.

FIG. 10 is an elevational view, partially in section, of the hub shownin FIG. 5 being secured to the helical coil of the delivery system shownin FIG. 8.

FIGS. 11A-11E are schematic views of a patient's left ventricularchamber illustrating the deployment of the partitioning device shown inFIGS. 1 and 2 with the delivery system shown in FIG. 8 to partition apatient's heart chamber (left ventricle) into a primary productiveportion and a secondary, non-productive portion.

FIG. 12 is a schematic plan view of the deployed device shown in FIG.11E within a patient's heart chamber.

FIG. 13 is a schematic plan view of the partitioning device shown inFIG. 1 without the expansive strand after deployment within a patient'sheart chamber.

FIG. 14 is a partial schematic view of the partitioning device shown inFIGS. 1 and 2 in a contracted configuration resulting from pulling thefree ends of the expansive strand at the periphery of the reinforcedmembrane.

FIG. 15 is a schematic view of the contracted device shown in FIG. 14being pulled into an expanded distal end of a receiving catheter tofacilitate withdrawal of the partitioning device into a receivingcatheter.

FIG. 16 is a schematic view of the contracted device shown in FIG. 14pulled further into the inner lumen of the receiving catheter.

FIG. 17 is a perspective view of the bottom of an alternativepartitioning device which has swellable pads disposed between adjacentribs to press the membrane between the ribs against the heart wall.

FIG. 18 is a cross-sectional view of a swellable pad disposed betweentwo membrane layers secured to the ribs of the partitioning device.

FIG. 19A is a cross-sectional side view of a human heart with thecatheter inserted therein.

FIGS. 19B-19K are cross-sectional side views of the human heartillustrating installation (FIGS. 19B-19E), removal (FIGS. 19E-19H), andsubsequent final installation (FIGS. 191-19K) of the cardiac device.

FIG. 20A is a perspective view of a cardiac device according to afurther embodiment of the invention.

FIG. 20B is a cross-sectional side view of the cardiac device of FIG.20A.

FIG. 20C is a cross-sectional side view of the human heart with thecardiac device of FIG. 20A installed.

FIGS. 21A-21C illustrate a variation of a partitioning device having aninflatable seal. FIG. 21 shows the device in the collapsed (delivery)configuration, while FIG. 21B shows a partially expanded view. FIG. 21Cshows a partial cut-away view of the device of FIGS. 21A and 21B.

FIGS. 22A and 22B show a partitioning device having a containerconfigured to be positioned within the non-productive portion of aventricle when the device is delivered to a ventricular chamber, asillustrated in FIG. 22B.

FIGS. 23A and 23B, respectively, show a bottom and side perspective viewof another variation of a partitioning device including a containerportion.

FIGS. 24A and 24B show side perspective and top views, respectively ofanother variation of a partitioning device having both a container and avalved port for filling the container.

FIGS. 25A and 25B illustrate operation of a partitioning device similarto that shown in FIGS. 24A and 24B.

FIG. 26 shows a delivery catheter for a partitioning device having avalved container.

FIG. 27 illustrates operation of a delivery catheter similar to thedelivery catheter shown in FIG. 26.

FIG. 28 illustrates one method of implanting a partitioning device asdescribed herein.

FIGS. 29A and 29B illustrate another variation of a method of using apartitioning implant.

FIG. 29C illustrates an alternative method of operating a portioningdevice similar to the version shown in FIG. 29B.

FIGS. 30A and 30B show another variation of a partitioning deviceincluding an inflatable sealing element.

FIG. 30C and 30D illustrate operation of the device shown in FIG. 30Aand 30B.

FIGS. 31A and 31B show another variation of a partitioning deviceincluding an inflatable element that may be used to expand the device.

DETAILED DESCRIPTION OF THE INVENTION

Partitioning devices, systems including partitioning devices, andmethods of using partitioning devices to treat subjects are describedherein. In general, the partitioning devices described herein areconfigured to partition a heart chamber, and in particular a ventricularchamber, into a productive portion and a non-productive portion. Thesepartitioning devices may be delivered in a collapsed configuration(e.g., percutaneously), and expanded within the ventricle and secured inposition within the ventricle, thereby partitioning it. The partitioningdevices described herein both secure to the heart wall (e.g., byanchors, barbs, spikes, etc.) and also (and possibly separately) seal tothe heart wall. Sealing to the wall of a heart chamber may becomplicated or made difficult by the presence of trabeculations and wallirregularities. Thus, the devices described herein may include one ormore sealing elements that are configured to help seal the device (e.g.,the partitioning membrane of the device) to the heart wall.

The partitioning devices described herein may also be configured so thatthe non-productive region formed by the partitioning device may befilled after it is deployed. Filling the non-productive portion mayprevent leak, and may also help secure the device in position. Asdescribed in detail below, any appropriate filling material may be used,including occlusive material such as coils, fluids (saline, blood,etc.), or the like.

Also described below are variations of partitioning devices that includeone or more containers. A container may be referred to as a compartment,chamber, bag, or the like. Partitioning devices including containers maybe deployed into the heart (e.g., in the ventricle), so that thecontainer portion is within (or at least partially forms) thenon-productive region. In some variations, portions of the partitioningdevice are contained within the container. The container may be filledor fillable, and may include one or more ports for filing. The ports maybe valved, and may include one-way valves so that the container does notleak. Thus, the container may be fluid-tight. The container may belocated distally to the pressure-receiving membrane of the device (whichmay form a portion or wall of the chamber), and may fill all or most ofthe non-productive space. In some variations the chamber includesanchors (e.g., hooks, barbs, adhesive, etc.) to secure the chamber tothe wall of the ventricle. These anchors may be in addition to otheranchors or securing elements on the device (e.g., around the perimeterof the pressure-receiving membrane).

For example, FIGS. 1-4 illustrate one variations of a partitioningdevice 10 which includes a partitioning membrane (e.g.,pressure-receiving membrane) 11, a hub 12, preferably centrally locatedon the partitioning device, and a radially expandable reinforcing frame13 is secured to the proximal or pressure side of the frame 13 as shownin FIG. 1. The ribs 14 have distal ends 15 which are secured to the hub12 and free proximal ends 16 which are configured to curve or flare awayfrom a center line axis. Radial expansion of the free proximal ends 16unfurls the membrane 11 secured to the frame 13 so that the membranepresents a pressure receiving surface 17 which defines in part theproductive portion of the patient's partitioned heart chamber. Theperipheral edge 18 of the membrane 11 may be serrated as shown.

In this example, the device includes a sealing element that is acontinuous expansive strand 19 that extends around the periphery of themembrane 11 on the pressure side thereof to apply pressure to thepressure side of the flexible material of the membrane to effectivelyseal the periphery of the membrane against the wall of the ventricularchamber. The ends 20 and 21 of the expansive strand 19 are shownextending away from the partitioning device in FIGS. 2 and 3. The ends20 and 21 may be left unattached or may be secured together, e.g. by asuitable adhesive or the membrane 11 itself. While not shown in detail,the membrane 11 has a proximal layer secured to the proximal faces ofthe ribs 14 and a distal layer secured to the distal faces of the ribsin a manner described in co-pending application Ser. No. 10/913,608,filed on Aug. 5, 2004.

The hub 12 shown in FIGS. 4 and 5 may connect to a non-traumatic supportcomponent 22. The support component 22 has a stem 23 a plurality of podsor feet 24 extending radially away from the center line axis and theends of the feet 24 are secured to struts 25 which extend betweenadjacent feet. A plane of material (not shown) may extend betweenadjacent feet 24 in a web-like fashion to provide further support inaddition to or in lieu of the struts 25. The inner diameter of the stem23 is threaded to secure the partitioning device 10 to a deliverycatheter as shown in FIGS. 8-10.

In the variation shown in FIG. 5, the distal ends 15 of the ribs 14 aresecured within the hub 12 and, as shown in FIG. 6, a transverselydisposed connector bar 26 may be secured within the hub which isconfigured to secure the hub 12 to the atraumatic support component 22.

As illustrated in FIGS. 5 and 6, the connector bar 26 of the hub 12allows the partitioning device 10 to be secured to the non-traumaticsupport component 22 and to be released from the delivery system withinthe patient's heart chamber. The distal ends 15 of the reinforcing ribs14 are secured within the hub 12 in a suitable manner or they may besecured to the surface defining the inner lumen or they may be disposedwithin channels or bores in the wall of the hub 12. The distal end ofthe ribs 14 are pre-shaped so that when the ribs are not constrained,other than by the membrane 11 secured thereto (as shown in FIGS. 1 and2), the free proximal ends 16 thereof expand to a desired angulardisplacement away from the centerline axis which is about 20° to about90°, preferably about 50° to about 80°. The unconstrained diameter ofthe partitioning device 10 may be greater than the diameter of the heartchamber at the deployed location of the partitioning device so that anoutward force is applied to the wall of the heart chamber by thepartially expanded ribs 14 during systole and diastole so that theresilient frame 13 augments the heart wall movement.

FIG. 7 illustrates the curved free proximal ends 16 of ribs 14 which areprovided with sharp tip elements 27 configured to engage and preferablypenetrate into the wall of the heart chamber and hold the partitioningdevice 10 in a deployed position within the patient's heart chamber soas to partition the ventricular chamber into a productive portion and anon-productive portion.

FIGS. 8-10 illustrate one variations of a delivery system 30 fordelivering a partitioning device 10 such as the one shown in FIGS. 1 and2 into a patient's heart chamber and deploying the partitioning deviceto partition the heart chamber as shown in FIGS. 11A-11E. This exampleof a delivery system 30 includes a guide catheter 31 and a deliverycatheter 32.

The guide catheter 31 has an inner lumen 33 extending between theproximal end 34 and distal end 35. A hemostatic valve (not shown) may beprovided at the proximal end 34 of the guide catheter 31 to seal aboutthe outer shaft 37 of the delivery catheter 32. In this example, theguide catheter includes a flush port 36 on the proximal end 34 of guidecatheter 31 that is in fluid communication with the inner lumen 33.

The delivery catheter 32 has an outer shaft 37 with an adapter 38 on theproximal end thereof having a proximal injection port 39 which is influid communication with the interior of the shaft 37. As shown in moredetail in FIG. 9, the outer shaft 37 has an inner shaft 41 which isdisposed within the interior thereof and is secured to the inner surfaceof the outer shaft 37 by webs 43 which extend along a substantial lengthof the inner shaft. The injection port 39 is in fluid communication withthe passageways 42 between the inner and outer shafts 41 and 37respectively and defined in part by the webs 42. A torque shaft 44,which is preferably formed of hypotubing (e.g. formed of stainless steelor superelastic NiTi), is disposed within the inner lumen 45 of theinner shaft 41 and has a proximal end 46 secured within the adapter 38.Balloon inflation port 47 is in fluid communication with the inner lumen48 of the torque shaft 44. In some variations, additional passagewaysmay be present in the delivery catheter. For example, a fillingpassageway may be included that may be used to fill the non-productiveregion behind the partitioning device with one or more fillers (e.g.,coils, fluids, etc.). In some variations, an additional inflation lumenmay be included for inflating a sealing element (e.g., a sealingballoon).

Torque shaft 44 may be rotatably disposed within the inner lumen 45 ofthe inner shaft 41 and secured to rotating knob 49. A helical coil screw50 may be secured to the distal end 51 of the torque shaft 44 androtation of the torque knob 49 on the proximal end 46 of the torqueshaft 44 rotates the screw 51 to facilitate deployment of a partitioningdevice 10. The proximal end 52 of inflatable balloon 53 may be sealinglysecured by adhesive 54 about the torque shaft 44 proximal to the distalend 51 of the torque shaft. The balloon 53 may have an interior 55 influid communication with the inner lumen 48 of the torque shaft 44.Inflation fluid may be delivered to the balloon interior 55 through port47 which is in fluid communication with the inner lumen 48 of the torqueshaft 44. The distal end 56 of the balloon 53 in this example issealingly secured by adhesive 57 to the helical screw 50. The proximaland distal ends 52 and 56 of the balloon 53 are blocked by the adhesivemasses 54 and 57 to prevent the loss of inflation fluid delivered to theinterior 55 of the balloon 53. Delivery of inflation fluid through afluid discharge port 58 in the distal end 51 of the torque shaft 44inflates the balloon 53 which in turn applies pressure to the proximalsurface of the partitioning device 10 to facilitate securing thepartitioning component 10 to the wall 59 of heart chamber 60 as shown inFIGS. 11A-11E discussed below.

In the example shown in FIG. 11A, the partitioning component 10 isdelivered through a delivery system 30 which includes a guide catheter31 and a delivery catheter 32. The partitioning component 10 iscollapsed in a first, delivery configuration which has small enoughtransverse dimensions to be slidably advanced through the inner lumen 33of the guide catheter 31. Preferably, the guide catheter 31 has beenpreviously percutaneously introduced and advanced through the patient'svasculature, such as the femoral artery, in a conventional manner to thedesired heart chamber 60. The delivery catheter 32 with the partitioningcomponent 10 attached is advanced through the inner lumen 33 of theguide catheter 31 until the partitioning component 10 is ready fordeployment from the distal end of the guide catheter 31 into thepatient's heart chamber 60 to be partitioned.

As shown in FIG. 11B, the partitioning component 10 mounted on the screw50 is urged further out of the inner lumen 33 of the guide catheter 32until the support component 22 engages the heart wall 59. The guidecatheter 31 is withdrawn while the delivery catheter 32 is held in placeuntil the proximal ends 16 of the ribs 14 exit the distal end 35 of theguide catheter. As shown in FIG. 11C, the free proximal ends 16 of ribs14 expand outwardly to press the sharp proximal tips 27 of the ribs 14against and preferably into the tissue lining the heart wall 59.

With the partitioning component 10 deployed within the heart chamber 60and preferably partially secured therein, inflation fluid is introducedthrough the inflation port 58 in the distal end 51 torque shaft 44 whereit is directed into the balloon interior 54 to inflate the balloon 53.The inflated balloon 53 presses against the pressure receiving surface17 of the membrane 11 of the partitioning component 10 to ensure thatthe sharp proximal tips 27 are pressed well into the tissue lining theheart wall 59 as shown in FIG. 11D.

In some variations, the partitioning device may include one or moreinflatable elements that may be used to expand the device (or assistwith expansion), as describe in greater detail below in reference toFIGS. 30A-30D. Thus the applicator (e.g., guide and/or deliverycatheters) may not include an inflatable balloon 53. Instead, theapplicator may include a connector to connect to the inflatable elementson (e.g., the periphery of ) the partitioning device.

With the partitioning device 10 properly positioned within the heartchamber 60, the knob 49 on the torque shaft 44 (as shown in FIG. 8) isrotated counter-clockwise to disengage the helical coil screw 50 of thedelivery catheter 32 from the stem 23 secured within hub 12. Thecounter-clockwise rotation of the torque shaft 44 rotates the helicalcoil screw 50 which rides on the connector bar 26 secured within the hub12. Once the helical coil screw 50 disengages the connector bar 26, thedelivery system 30, including the guide catheter 31 and the deliverycatheter 32, may then be removed from the patient.

The proximal end 34 of the guide catheter 31 in this example is providedwith a flush port 36 to inject fluids such as therapeutic, diagnostic orother fluids through the inner lumen 33 during the procedure. Similarly,the proximal injection port 39 of adapter 38 is in communication withpassageways 43 if the delivery catheter 32 for essentially the samepurpose.

The deployment of the partitioning component 10 in the patient's heartchamber 60 as shown in FIG. 11E divides the chamber into a mainproductive or operational portion 61 and a secondary, essentiallynon-productive portion 62. The operational portion 61 is smaller thanthe original heart chamber 60 and provides for an improved ejectionfraction and an improvement in blood flow. Over time, the non-productiveportion 62 may fill first with thrombus and subsequently with cellulargrowth. Bio-resorbable fillers such as polylactic acid, polyglycolicacid, polycaprolactone and copolymers and blends may be employed toinitially fill the non-productive portion 62. Fillers may be suitablysupplied in a suitable solvent such as dimethylsulfoxide (DMSO). Othermaterials which accelerate tissue growth or thrombus may be deployed inthe non-productive portion 62 as well as non-reactive fillers. Fillersmay include solid materials or liquid materials, or both, and mayinclude material that expands after being loaded into the non-productiveportion or a chamber within the non-productive portion. For example, thefiller may be a coil such as a vasoocclusive coil.

As described in greater detail below, the partitioning devices describedherein may also be sealed against the wall(s) of the heart, so that thematerial used to fill does not leak (or does not substantially leak. Insome variations a chamber (e.g., bag) may also be part of thepartitioning device and may be positioned within the non-productiveportion and be filled by the filler.

FIG. 12 is a top view of the deployed partitioning device shown in FIG.11E schematically illustrating the sealed periphery of the membrane 11against the ventricular wall. This is to be compared with the schematicpresentation shown in FIG. 13 which illustrates a partitioning devicewithout a sealing element such as a strand (or other expandable sealingelement) having folds along the periphery 18 which do not allow for aneffective seal against the wall 59 of the heart chamber 60. Thepartitioning device 10 may be conveniently formed by the methoddescribed in co-pending application Ser. No. 10/913,608, filed on Aug.5, 2004, which is incorporated herein by reference.

While porous ePTFE material is preferred, the membrane 11 may be formedof suitable biocompatible polymeric material which includes Nylon, PET(polyethylene terephthalate) and polyesters such as Hytrel. The membrane11 may be foraminous in nature to facilitate tissue ingrowth afterdeployment within the patient's heart. The delivery catheter 32 and theguiding catheter 31 may be formed of suitable high strength polymericmaterial such as PEEK (polyetheretherketone), polycarbonate, PET, Nylon,and the like. Braided composite shafts may also be employed.

FIGS. 14-16 illustrate the collapse and retrieval of a partitioningdevice 10 by pulling on the ends 20 and 21 of the expansive strand 19which extends around the periphery of the membrane 11. Typically, thepartitioning device 10 would still be secured to the delivery catheter32, but the delivery catheter is not shown to simplify the drawings. InFIG. 14 the partitioning device 10 is shown in a partially collapsedconfiguration. In FIG. 15 the partially collapsed partitioning device 10is shown being withdrawn into the flared distal end 63 of retrievalcatheter 64. FIG. 16 illustrates the completely collapsed partitioningdevice 10 pulled further into the retrieval catheter 64. Thepartitioning device 10 may be withdrawn by pulling the device throughthe inner lumen 65 of the retrieval catheter 64. Optionally, thepartitioning device 10 and retrieval catheter may be withdrawn from thepatient together.

To assist in properly locating the device during advancement andplacement thereof into a patient's heart chamber, parts, e.g. the distalextremity, of one or more of the ribs 14 and/or the hub 12 may beprovided with markers at desirable locations that provide enhancedvisualization by eye, by ultrasound, by X-ray, or other imaging orvisualization means. Radiopaque markers may be made with, for example,stainless steel, platinum, gold, iridium, tantalum, tungsten, silver,rhodium, nickel, bismuth, other radiopaque metals, alloys and oxides ofthese metals.

FIGS. 17 and 18 illustrate an alternative design which illustrates apartitioning device 10 that includes an expandable sealing element. Inthis example, the expandable sealing elements are a plurality ofswellable bodies 70, preferably hydrophilic foam, around the peripheryof the membrane 11 between adjacent ribs 14. When these bodies contactbody fluid, such as blood, upon deployment, they swell, thereby sealingthe peripheral portion of the membrane 11 against the patient's heartwall as previously described. The details of the partitioning device 10may be essentially the same as in the previous embodiment and elementsin this alternative embodiment are given the same reference numbers assimilar elements in the previous embodiments.

To the extent not otherwise described herein, the various components ofthe partitioning device and delivery system may be formed ofconventional materials and in a conventional manner as will beappreciated by those skilled in the art.

FIGS. 19A-19J illustrate application of another variation of apartitioning device 134 being deployed in a human heart 242. The heart242 contains a right ventricle 244 and a left ventricle 246 withpapillary muscles 248 and an akinetic portion 250 with an apex 252. Thedistal end of the catheter 138 has been inserted through the aorta andaortic valve into the left ventricle 246 to a selected position wherethe cardiac device 134 can be deployed. The catheter tube 138 is thenpartially pulled off of the cardiac device 134 exposing the stem 186.

The active anchor 236 is then deployed by rotating the anchor knob 58 ina first direction. The active anchor 236 penetrates the myocardium ofthe heart 242 to secure the cardiac device 134 in the selected positionat the apex 252 of the akinetic portion 250 of the left ventricle 246.In some variations the device does not include an active (e.g., distal)anchor, but may include an atraumatic foot, as described above.

The catheter 138 is then completely removed from the distal end 54 ofthe deployment member 46, exposing the cardiac device 134. As thecardiac device 134 expands, due to the resilient nature of the segments192 and the pre-set shape of the frame 184, the passive anchors 214 onthe segments 192 penetrate the myocardium in a first direction. Themembrane 194 seals a portion of the ventricle 246 and separates theventricle 246 into two volumes.

If the cardiac device 134 has not been properly positioned, or if it isof the wrong size or shape for the particular heart, the device 134 maybe repositioned or completely removed from the heart 242.

FIG. 20A and FIG. 20B illustrate another variation of a cardiac (orpartitioning) device 288. This example of a partitioning device 288includes a sealing element that is configured as a second membrane 300having fibers (or fringe) 304 that acts to seal against the ventriclewall. The partitioning device 288 in FIGS. 20A-20B includes a first hub290, a first frame 292, a second hub 294, a second frame 296, a firstmembrane 298, and a second membrane 300. The first hub 290 is attachedto a central portion of the first frame 292. A plurality of segments 302extend radially from and upwards from the first hub 290. The firstmembrane 298 is occlusive and made of a thrombogenic material andstretched between the segments 302 to form a first cone-shaped body. Aplurality of fibers 304 extend radially from an outer edge 306 of thefirst cone-shaped body. An active anchor 308 extends down from the firsthub 290.

The second frame 296 includes a plurality of segments 310 extendingradially and upwardly from the second hub 294 and end in sharp passiveanchors 312. An attachment screw 314, similar to the detachment screw214, extends downwards from the second hub 294. Referring specificallyto FIG. 20B, the attachment screw 314 is rotated so that it engages apin 321 within the first hub 290, similarly to the frame hub 190 alreadydescribed, to secure the second frame 296 to the first frame 292. Thesecond membrane 300 is made of ePTFE and stretched between the segments310 to form a second cone-shaped body.

FIG. 20C illustrates a human heart with the partitioning device 288 ofFIG. 20A secured to an akinetic portion thereof. The fibers 304 on theouter edge 306 of the first frame 292 are interacting with an innersurface of the left ventricle to seal off the volume below the outeredge 306 of the first frame 292. The passive anchors 312 on the ends ofthe segments 310 of the second frame 296 have penetrated the myocardiumto hold the device 288 in place.

A further advantage of this embodiment is that the fibers 304 of thefirst membrane 298 interface with trabeculae and further block the flowof blood into the apex of the akinetic portion.

In another variation of the partitioning device described herein, thedevice includes a plurality of strands extending from the distal side ofthe device. Thus, the sealing element comprises a plurality of strandsor braids that extend from the portion of the device within thenon-productive side of the device. These braids may press against aninner surface of the ventricle, and help seal the device within theventricle.

In some variations the sealing element is an inflatable sealing element.For example, the inflatable sealing element may be a swellable element,as described above in FIGS. 17 and 18, which inflates with fluid toswell. Alternatively, the device may include an inflatable sealingelement configured as a balloon, as shown in FIGS. 21A-21C.

FIG. 21A illustrates one variation of a partitioning device in acollapsed or delivery configuration. The device includes a plurality ofribs 2101 to which a membrane 2109 is connected. The ribs connect to acentral hub 2111 which connects to an atraumatic foot 2113 in thisexample. The peripheral region of the membrane includes an inflatableballoon sealing element 2103 having a valve 2015. In FIG. 21 A thesealing balloon element 2103 is shown collapsed. The device may beinflated after expanding in the ventricle, or it may be inflated to helpexpand the device. As mentioned, the delivery catheter may be adapted tocommunicate with the valve and inflate the device.

Although the valve 2015 for inflation is shown in this example on theperiphery of the partitioning device, in some variations, the valve maybe located near the center (e.g., radially) of the partitioning device,so that it may be attached to an inflation port on the applicator. Insome variations, the partitioning device may include more than onevalve.

FIG. 21B shows the partitioning device of FIG. 21C in the (at leastpartially) expanded configuration, in which the balloon around theperiphery of the membrane is inflated. As with the swellable variationof the inflatable sealing element, the balloon may be located at thevery periphery of the membrane, or it may be positioned more centrally(e.g., towards the centerline of the device), but still configured toapply pressure to urge the membrane against the wall of the heart andthereby seal the membrane to the wall. FIG. 21C shows a partial cut-awayversion of the inflatable balloon sealing element, including the passiveanchors 2111 at the ends of the implant ribs or struts 2101.

FIGS. 30A-30D illustrate another variation of a partitioning devicehaving an inflatable sealing element. In this example, the inflatablesealing element is a plurality of inflatable elements 3003 that aredistributed around the perimeter of the device 3001. As mentioned,inflation of these elements may both expand the partitioning membraneinto the deployed form, and may also help seal the membrane against thewall of the ventricle. Thus, the expandable element may provide bothcircumferential and radial expansion of the partitioning device. Forexample, FIG. 30A shows a top view of the device indicating thepartitioning membrane 3007 (having a peripheral region 3009), and theplurality of expandable and inflatable elements 3003. The inflatableelements may be inflated by one or more inflation channels 3011, whichmay be connected to a port and/or valve that can be connected to theapplicator or other source of inflation material (gas, fluid, etc.).

The inflatable balloon or plurality of balloons at or near the peripheryof the membrane of the partitioning device may be formed from the samematerial as the membrane. For example, the balloon may be integral withthe membrane by forming cavities between two layers forming themembrane. For example, the membrane may be formed of two layers of ePTFEsandwiched together. In some variations, the struts or arms arelaminated between the two layers. As shown in FIG. 30A and 30B, aportion of the membrane may be inflatable by preventing them fromsealing (laminating) together.

The inflatable element(s) may be connected via an inflation channel 3011or a plurality of inflation channels 3011, as shown in FIG. 30A, to aport or valve. As mentioned, the valve may be located in any appropriatelocation so that it may couple with an inflation source. For example, avalve may be positioned in the hub (center) region that typically mateswith the applicator. One or more inflation channels (or inflation ports)may be used. For example, in FIG. 30A, the device includes a pluralityof inflation channels distributing inflation material to all of theinflatable balloon elements. When a plurality of inflatable balloonelements are used, the device, each inflatable balloon element may beseparately inflatable, or all (or a subset) of the inflatable elementsmay be connected together so as to inflate together.

As mentioned above, any appropriate inflation material may be used,including liquids (e.g., saline), gases, solids, gels, etc. In somevariations, the inflatable element(s) described herein may be filledwith a contrast agent that may help visualize the partitioning device.For example, the inflatable elements may be filled with a radioopaquecontrast media that allows visualization of the partitioning deviceafter it has been deployed in the left ventricle. In some variations,such as the partitioning device shown in FIG. 30B, the periphery of themembrane may be visualized by inflating with a contrast material 3031.

In some variations, the inflation material is a polymerizable orcurable. For example, the inflatable elements (e.g., balloon elements)may be inflated with a curable material including a UV curable materialor an RF curable material. For example, the filling material may includea UV-curable filling material. Thus, an applicator may also includes alight-emitting element such as a fiber optic cable and/or a port for anenergy source that can apply the energy (light, heat, etc.) to cure orotherwise modify the material in the inflatable element.

In some variations, the partitioning device may include channels orpathways that may be inflated with a curable material to form one ormore of the struts. For example, in FIG. 30A, channels 3011 may beformed within the membrane 3007 either for filing the inflatableelements 3003, or simply to form inflatable struts. These inflatablestruts may be filled with a curable material, as mentioned above, whichmay provide additional structural support. For example, when themembrane is formed by lamination or otherwise securing two or morelayers, the struts or other inflatable members may be formed betweenthem (e.g., in non-adhesive regions). Alternatively, inflatable regionsmay be attached to the membrane(s). In some variations, the partitioningdevice may therefore include one or more inflatable struts that areformed in vivo, for example, using an elastomeric (e.g., RTV-like)curable material. In some variations the inflatable struts extendradially (e.g., from a common hub region), towards to the distal end ofthe membrane. The inflatable struts may communicate with inflatablemembers including inflatable balloon members 3003, as shown in FIG. 30A,or they may not communicate with other inflatable regions, but mayterminate or include one or more ports.

The inflatable balloon element(s) may be located at or near theperipheral edge of the device. For example, in FIG. 30A, the inflatableballoon elements are located just proximal to the peripheral edge of thedevice, so that a portion of the membrane extends distally past theinflatable element. This edge portion may be loose, serrated, (or mayform a plurality of flaps), and may help seal the device to the wall ofthe ventricle. In some variations, the inflatable element is at theperiphery of the partitioning device.

FIG. 30B illustrates a side view of the partitioning device of FIG. 30A,showing the inflatable balloon elements near the proximal edge of themembrane.

In use, the inflatable balloon elements may be expanded to open thepartitioning device. For example, upon inflation, the inflatableelements may push the expansion of the struts of the device, therebyencouraging radial expansion of the membrane. The inflatable balloonelements may also be configured to accommodate non-circular deploymentwithin the ventricle. FIGS. 30C and 30D illustrate different variationsof partitioning devices including inflatable balloon elements that mayconform to non-circular (or otherwise irregular) walls of the heart. Forexample, in FIG. 30C, the plurality of inflatable elements shown 3003may be inflated so that they provide outward (axially) force to expandthe device, and also to seal the device against the ventricle wall, butthe plurality of inflatable elements also accommodate irregularitiesbecause the size of the sub-regions that include an inflatable balloonelement may be displaced without disrupting the rest of the membrane. InFIG. 30C, one region of the partitioning device 3023 is allowed tofollow a contour of the heart wall that is not round. For example, wheretrabeculations or other projections in the ventricle wall make itirregular. Similarly, when the body region (e.g., ventricle) is notrounded but is oval or otherwise non-circular, the inflatable balloonelements as shown in FIG. 30D may allow it to conform to the walls.

In some variations, an inflatable balloon may be included in thepartitioning device that is not located on or near the periphery of themembrane. For example, FIGS. 31A and 31B illustrate one variation inwhich the central region of the implant (e.g. near the hub) on themembrane is inflatable, and inflation may help rapidly expand thepartitioning device.

For example, in FIG. 31A, the partitioning device 3101 includes one ormore inflatable regions 3103 that are located on the membrane 3107.These inflatable region or regions may also be formed between two of thelayers forming the membrane, as mentioned above. For example, two layersof ePTFE forming the membrane may be sealed near the outer periphery3109 of the device, but allowed to be separate closer to the hub, sothat this region may be inflated. A port or ports for inflation(including or more valves) may also be included. In addition to theinflatable elements shown in FIG. 31A, other variations may also includeone or more other sealing elements (e.g., a strand, a peripheralinflatable element, etc.) for helping to secure the membrane to theventricle walls. In some variations the edges of the membrane may alsobe loose, serrated, etc., so as to help form a seal.

The partitioning device of FIG. 30A is shown in partially transparentside-view in FIG. 30B. In this example, the inflatable elements 3103(which may also be referred to as inflatable expanding elements orinflatable expanding balloon elements) are indicated. Although theseelements may drive the membrane open and towards the wall of theventricle, they are not necessarily sealing elements, since they do notnecessarily tension the membrane (e.g., removing wrinkles) to seal, incontrast to the device shown in FIG. 30A-30D. They may be used incombination with other sealing elements, as mentioned.

FIGS. 22A-25B illustrate variations of the devices including a containersurrounding a portion of the partitioning device, and configured to bepositioned within the non-productive portion of the heart chamber whenthe device is deployed in a heart chamber. For example, FIG. 22A shows across-section through one variation of a partitioning device in whichthe implant includes a frame of ribs or struts 2203 and a membraneconnected to the frame 2205. One or more passive anchors (e.g., prongs,hooks, etc.) 2213 may be located on the ends of each strut. In thisexample, the membrane is formed of ePTE, and may be laminated over theframe to form the pressure-receiving surface of the device. The implantalso includes a foot 2207 that is relatively soft (e.g., atraumatic) sothat it doesn't penetrate the tissue wall, even when the wall may beweakened or akinetic. In this example, the device also includes acontainer 2232 formed by the pressure-receiving membrane and a secondmembrane (e.g., an ePTFE membrane) extending distally around the portionof the device that will be positioned within the non-productive portionof the membrane, as illustrated in FIG. 22 b. In FIGS. 22A and 22B thecontainer is configured as a bag, the top of which is sealed by thepressure-receiving membrane 2205. The device may include one or moreports 2209 (which may include valves) for filling the container. In FIG.22A, the ports are configured as skives 2209 through which material maybe injected to fill the container. FIG. 22B illustrates the device ofFIG. 22A implanted into a ventricle (a left ventricle 2221). In thisexample, saline 2223 has been injected to fill the container, whichcontacts the wall of the apex region 2225 of the left ventricle 2221.

FIG. 23A and 23B show perspective views of a similar variation.

FIG. 24A is another example of a portioning device that includes anocclusive membrane 2403 secured to a plurality of ribs or struts 2405.The device also includes a container 2432 which, similar to thevariation shown in FIGS. 22A-23B, is an inflatable bag-like structureformed of ePTFE. The example shown in FIG. 24A also includes a valve,configured as a flap valve, 2435, which is a membrane of ePTFE thatcovers openings (e.g., skives) through which the container may befilled. The membrane may be biased (e.g., by the elastic structure ofthe valve, and/or by pressure from within the container) so that itopens for filling, but does not permit a significant amount of materialto leave the container. Thus the container may be filled through theimplant hub 2409. For example, the container may be filled using thedelivery catheter (not shown). The hub portion 2409 and an atraumaticfoot region 2401 are shown positioned within the container. In somevariations, the container may surround the foot region and/or the hub,but not enclose them.

FIG. 24B shows a top view of the device of FIG. 24A, illustrating theopenings 2409 (skives) into the container that are selectively coveredby the flap valve 2435. These openings may also be configured so thatfluid, such as blood from within the ventricle, can be loaded into thechamber once it is positioned. An example of this is shown in FIGS. 25Aand 25B. In this example, the device is shown expanded within aventricle 2500. The flap valve allows blood (e.g., blood being pumpedthrough the ventricle) to enter the container 2432, as indicated by thearrows 2439. This may inflate the container within the ventricle, sothat the walls of the container conform to the wall of thenon-productive region of the ventricle, i.e., the region behind thepartitioning membrane 2403 and ribs 2405. For example, during the periodof contraction of the ventricle when blood is pushed against thepressure-receiving membrane of the device as the ventricle fills (e.g.,diastole), blood may enter and fill the chamber. When the ventriclecontracts (e.g., systole), blood is held in the chamber since the flapvalve is configured to prevent blood from leaving the chamber. After thechamber is filled, blood may be held within the chamber and preventedfrom exiting the chamber by the flap valve, as indicated by the arrows2439′ in FIG. 25B. Thus, this variation may be self-filling.

FIG. 26 illustrates one variation of an applicator that may be used witha partitioning device such as the partitioning devices includingchambers illustrated above. In FIG. 26, the applicator is a deliverycatheter 2603 that may be used with a guide catheter 2601. The guidecatheter 2601 in this example has an inner lumen extending between theproximal end 2604 and distal end. A hemostatic valve (not shown) may beprovided at the proximal end 2604 of the guide catheter 2601 to sealabout the outer shaft of the delivery catheter 2602. In this example,the guide catheter also includes a flush port 2606 on the proximal end2604 of guide catheter 2601 that is in fluid communication with theinner lumen.

The applicator delivery catheter 2603 (“applicator”) has an elongatedouter shaft 2612 with an inflation port (e.g., deployment inflation port2615) near the proximal end. The inflation port may be used to inflatean inflatable member on the distal portion of the elongate shaftconfigured to help expand the device. This inflatable member may also bereferred to as a deployment balloon 2655. The deployment inflation portis in communication with an inner lumen in the delivery catheter andwith a deployment balloon 2655.

The applicator also includes a releaseable securing element aspreviously described, for releasably securing the implant device. Forexample, the releasable securing element may include a torque shaft andhelical coil screw as illustrated and described in FIG. 8, above.

The applicator may also include a filling interface 2621 near the distalend of the elongate shaft for filling the non-productive portion of theheart formed by the implant. In some variations, the filling interfacemay be configured as an inflation port for inflating or filling acontainer portion of the implant. The filling interface may beconfigured as a filling port, and may be used to fill the non-productiveregion after the implant has been deployed even if the implant does notinclude a container portion.

The system shown in FIG. 26 (including a delivery catheter or applicator2603, insertion catheter 2601, and expandable partitioning device 2605)may also be configured for use with a UV-curable filling material. Inthis variation, the applicator also includes a light-emitting elementsuch as a fiber optic cable 2633 near the distal end, and a port 2623for an energy source near the proximal end, so that energy (e.g.,UV-light) can be used to cure the filler in the non-productive regionand/or the container 2605.

The applicator may also include a handle 2621 at or near the proximalend.

FIG. 27 illustrates another variation of a system including apartitioning device 2705, and an applicator that is configured to deploya partitioning device and then deliver occlusive members (e.g., coils)into the non-productive portion formed behind the device. For example,in this variation the applicator 2700 includes a control handle 2701 anda balloon deployment inflation port 2709 at the proximal end, as well asan implant detachment knob 2711. Turning the implant detachment knob mayrotate the torque shaft (not visible) and deploy the implant, aspreviously described. The system may also include a delivery catheter2703.

In FIG. 27, the partitioning device 2705 is shown deployed within theapical region of a left ventricle 2715 so that the foot 2717 of thedevice rests against the wall and the pressure-receiving membrane formsa non-productive region 2719 separate from the productive region of theventricle 2716. The membrane may be reinforced with ribs or struts, andmay be anchored via one or more securing elements (not visible in thisexample).

In this variation, the applicator may also be used to apply occlusiveelements into the non-productive region 2719. As illustrated theocclusive elements are coils, e.g., thrombogenic coils 2733). Thus, theapplicator may include a port and passageway for the occlusive member.For example, the applicator may include a coil delivery catheter 2755,and may also include a coil detachment knob 2757. In operation, thecoils may be delivered behind the expanded implant by pushing the coilsout of the distal end from behind the deployed partitioning device untilthis region is filled as desired. The coil may then be detached,although multiple small coils may also be used. Any occlusive materialmay be used, including any variation of occlusive coil. For example,thrombogenic coils may be used in the non-productive portion.

FIG. 28 illustrates another variation of a partitioning device that canbe filled with an occlusive material such as a thrombogenic coil. Inthis variation the non-productive portion is filled after the device hasbeen deployed using a separate coil delivery device 2805. The coildelivery device (e.g., coil delivery catheter) may be used with the sameguide catheter 2703 used to by the applicator to position and deploy theimplant. The coil delivery catheter may be used to fill the regionbehind the device by filling from an edge of the device, by separatingthe edge of the membrane of the device from the wall of the heart toallow the distal end of the coil delivery device into the non-productivespace.

FIGS. 29A-29C illustrate another variation of the method of filling aportion of the non-productive region formed by a partitioning device2901 with an occlusive material(s) such as occlusive coils. FIG. 29Aillustrates one variation of a partitioning device 2901 that includes acontainer 2903 configured as a pouch or bag that is bounded on at leastone side by the pressure receiving membrane 2905. The pressure-receivingmembrane 2905 may be supported by struts 2907. In some variations thecontainer is not bounded by the pressure-receiving membrane. The implantfoot 2912 is within the container (which may also be referred to as abag or pouch).

In operation the device may be deployed in a heart chamber (e.g., theleft ventricle 2950) and the container may be filled with occlusivematerial. For example, FIG. 29B illustrates the partitioning device ofFIG. 29A filled with occlusive coils 2915. When the device is securedwithin the heart, as illustrated in FIG. 29C, the container may befilled so that virtually the entire non-productive portion is filled (bythe filled container).

While particular forms of the invention have been illustrated anddescribed herein, it will be apparent that various modifications andimprovements can be made to the invention. Moreover, individual featuresof embodiments of the invention may be shown in some drawings and not inothers, but those skilled in the art will recognize that individualfeatures of one embodiment of the invention can be combined with any orall the features of another embodiment. Accordingly, it is not intendedthat the invention be limited to the specific embodiments illustrated.It is intended that this invention to be defined by the scope of theappended claims as broadly as the prior art will permit.

As used herein, terms such a “element”, “member”, “component”, “device”,“section”, “portion”, “step”, “means” and words of similar import, shallnot be construed as invoking the provisions of 35 U.S.C. .sctn. 112(6)unless the following claims expressly use the term “means” followed by aparticular function without specific structure or the term “step”followed by a particular function without specific action. Accordingly,it is not intended that the invention be limited, except as by theappended claims. All patents and patent applications referred to hereinare hereby incorporated by reference in their entirety.

1. A device for partitioning a patient's ventricle into a productiveportion and a non-productive portion, the device comprising: a membraneand a membrane support frame sized to span the patient's ventricle,wherein the membrane support frame comprises a plurality of supportstruts configured to have a collapsed and an expanded configuration; atleast one securing element extending from the periphery of the membrane;and an inflatable sealing element on a peripheral portion of themembrane configured to seal the peripheral portion of the membrane to awall of the ventricle.
 2. The device of claim 1 wherein the inflatablesealing element extends annularly around the perimeter of the membrane.3. The device of claim 1, further comprising a plurality of inflatablesealing elements extending between the support struts.
 4. The device ofclaim 1 wherein the membrane support frame is configured to form arecess in the expanded configuration.
 5. The device of claim 1, furthercomprising a valve configured to allow access to the non-productiveportion when the device is deployed in the subject's ventricle.
 6. Thedevice of claim 5, wherein the valve comprises a one-way valve.
 7. Thedevice of claim 1 wherein the membrane is formed at least in part of aflexible material.
 8. The device of claim 1 comprising an inflationvalve fluidly connected to the inflatable sealing element.
 9. The deviceof claim 1 wherein the inflatable sealing element is formed of abioabsorbable material.
 10. The device of claim 9 wherein thebioabsorbable material is selected from the group consisting ofcollagen, gelatin, polylactic acid, polyglycolic acid, copolymers ofpolylactic acid and polyglycolic acid, polycaprolactone, mixtures andcopolymers thereof.
 11. The device of claim 1, further comprising acentral hub to which the membrane support frame is secured.
 12. Thedevice of claim 1, further comprising a stem with a non-traumatic distaltip configured to engage a region of the chamber defining in part thenon-productive portion thereof.
 13. The device of claim 1 wherein thesecuring element has a tissue penetrating tip.
 14. The device of claim 1wherein the securing element is outwardly curved.
 15. The device ofclaim 1, further comprising a container secured to the device andconfigured to be positioned within the non-productive portion of thesubject's ventricle when the device is deployed in the subject'sventricle.
 16. A method of treating a patient, comprising:percutaneously advancing a contracted partitioning device into apatient's ventricle; expanding the partitioning device into a deployedconfiguration within the ventricle; and sealing the expandedpartitioning component to the wall of the ventricle to separate theventricle into a productive portion and a non-productive portion toprevent communication between the productive portion and non-productiveportions.
 17. The method of claim 16, further comprising filling thenon-productive portion.
 18. The method of claim 16 wherein the sealingstep comprises expanding a sealing element against the ventricle wallfrom the partitioning device.
 19. The method of claim 16 wherein thesealing step comprises biasing a membrane toward the heart wall with thesealing element.
 20. The method of claim 16 wherein the expanding stepcomprises inflating an inflatable sealing element located near theperiphery of the partitioning device.
 21. A method of treating apatient, comprising: percutaneously advancing a contracted partitioningdevice into a patient's ventricle; expanding the partitioning deviceinto a deployed configuration within the ventricle; securing theexpanded partitioning device to the ventricle wall to separate theventricle into a productive portion and a non-productive portion; andadding a filling material to the non-productive portion after thepartitioning device has expanded.
 22. The method of claim 21 wherein thestep of adding a filling material applying material through a valve onthe partitioning device.
 23. The method of claim 21 wherein the step ofadding a filling material comprises applying a filling material into acompartment portion of the partitioning device through a valve.
 24. Themethod of claim 21, wherein the step of adding the filing materialcomprises passively allowing a blood to fill a compartment portion ofthe partitioning device through a valve on the device.
 25. The method ofclaim 21, wherein the step of adding the filing material comprisesapplying one or more coils to the non-productive portion.
 26. The methodof claim 21, wherein the step of adding the filing material comprisesapplying one or more coils to a compartment portion of the partitioningdevice.
 27. The method of claim 21, wherein the step of adding thefiling material comprises applying saline to a compartment portion ofthe partitioning device.
 28. An applicator for applying a partitioningdevice of a ventricle of a patient's heart, the applicator comprising:an elongated shaft which has proximal and distal ends; an deployinginflation port on the proximal end of the shaft and an inner lumen influid communication with the port; a releasable securing element on thedistal end of the elongated shaft configured to secure and release thepartitioning device; an inflatable deployment balloon on a distalportion of the elongated shaft having an interior in fluid communicationwith the deploying inflation port, wherein the inflatable deploymentballoon is configured to help expand the partitioning device; and afilling interface near the distal end of the elongated shaft, whereinthe filling interface is configured to apply a filling material througha valve on the partitioning device.